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Although none of the regulated markets have a biosimilar monoclonal antibody on the market yet, major players are getting more and more interested in this area…

Most of the top pharma companies, who were not interested in “simple” biosimilars (i.e. filgrastim, epoetin), have recently made agreements to develop and/or commercialize their own versions of monoclonal antibodies. And as a result of these changes, we wanted to summarize the current situation as the year comes to an end…

Biosimilar mAbs will be the hottest competitive area; only in 2010, Rituxan, an anti-CD20 chimeric mAb which is used in oncology and rheumatoid arthritis sold $6,6 billion worldwide.

Biosimilar monoclonal antibodies, which will be used for oncology indications, will reach more than $4 billion in sales in the U.S., France, Germany, Italy, Spain, U.K. and Japan by 2020, according to Decision Resource’s report. The same report also says that, the biosimilar versions of rituximab could be approved in 2013 in Europe.

As well-known, Rituxan/Mabthera is not the only target for biosimilar players; Herceptin (trastuzumab), Remicade (infliximab) are also in the same row.

SEVERAL COMPETITORSSandoz was the first company who was “fighting” for biosimilar approvals. As the generics division of pharma giant Novartis, Sandoz have launched biosimilar growth hormone, filgrastim and epoetin biosimilars till now.

They have an established position in the market, made agreements in the past and now developing monoclonal antibodies which make them the undisputed pioneer of biosimilars and the global leader, with 2010 sales of USD 185 million (+63% versus previous year), representing nearly 50% of the worldwide regulated market1. Sandoz has a Phase II rheumatoid arthritis trial for their own version of rituximab.

Teva and Hospira are other well-established companies for biosimilars. Teva, like Sandoz, has already launched growth hormone, epoetin, filgrastim biosimilars in the EU and they are developing rituximab and also pegylated filgrastim which are at the clinical stages for the time being. Teva expanded their expertise with the acqusition of Ratiopharm and is keeping on investing this area with their in-house capabilities2. Teva has collaboration agreements with Spectrum Pharmaceuticals and Lonza to be focused on monoclonal antibodies.

Hospira also has an in-house development capability with the acqusition of biosimilar filgrastim and its related manufacturing facility in 20093. Hospira has an agreement with Celltrion, a South Korean company which is developing biosimilar monoclonal antibodies. This agreement gives Hospira to launch Celltrion’s products in the US once their patents expire.

South Korea’s Celltrion has already initiated clinical trials for their own monoclonal antibody biosimilars4. They have Rituxan biosimilar in their portfolio but they also developed Herceptin and Remicade biosimilars already.

Merck, after creating its business unit Merck BioVentures, will try to launch six or more biosimilars between 2012 and 2017. Merck has already acquired Insmed which were developing Neupogen (filgrastim) and Neulasta (pegfilgrastim) biosimilars. Merck BioVentures has also signed an agreement with South Korea’s Hanwha to commercialize their Enbrel (etanercept) biosimilar but after Amgen’s patent declaration, this business is still under question in the U.S.5.

When we have look at the latest developments, we see that Stada, Cipla, Boehringer Ingelheim, Amgen with Watson, GE Healthcare, Samsung with Biogen Idec, Baxter with Momenta have all made their agreements to jump on this bandwagon.

In order to have biosimilars in their portfolio, some companies decided to make acqusitions, some partnerships. Companies like Sandoz, Amgen and Hospira have their own in-house capacities to develop biosimilars but they also make collaborations to be more strong.

Pfizer, has no development agreements but they also have an agreement to commercialize some of Biocon of India’s products. And according to the latest reports, Roche still plans to protect their biologics with focusing on innovative technologies, like biosimilars.

So, it is clear that, most of the major players have taken necessary actions to enter the biosimilar mAbs field. But due to the payors expectations, there are still more room to go and not only the big Pharma, but also the small biotech companies can find a way to stay ahead of their competitors.

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